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Re: kevli33 post# 196770

Monday, 06/17/2019 8:26:46 AM

Monday, June 17, 2019 8:26:46 AM

Post# of 458336
An important video w/Ms. Woodcock ref: FDA


She does a credible job of discussing w/open mind the kinds of issues we have reviewed here. Takeawys:

. FDA admits they have a problem and that their development processes are unsustainable and unresponsive.
. FDA is looking for some way to fill the middle ground on providing evidence paths for drug development. (HEY...look at the AVXL Consortium)
. FDA need to look at evidence based science which is timely and functional. (see Precision Medicine-too bad Dr.G. got no where fighting the political-FDA system)
. FDA need to establish a patient-sponsor system that is both responsive and effective.

There is more also. We have stated here before that the first step in solving a problem is to recognize that one exists. Looks like they are finally doing that. Now we will witness if they are capable of doing what any manager worth their pay in the private sector would do. FIX IT NOW.
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